Thrombopoietin Levels and Platelet Transfusion in Neonates

NCT ID: NCT00549484

Last Updated: 2008-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-09-30

Brief Summary

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Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production.

Detailed Description

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Thrombocytopenia, defined as a platelet count \< 150,000/mm3, is a very common hematologic problem in the neonatal period. Multiple etiologies are known to be associated with thrombocytopenia in neonates. Thrombopoietin (TPO) is known to be the central regulator of megakaryocyte and platelet production in adults and infants. However, the role of TPO in neonatal platelet regulation is not well understood. TPO levels have been shown to be higher in neonates with thrombocytopenia, with a decrease in TPO after resolution of the thrombocytopenia. The response of TPO levels in neonates after platelet transfusion has never been studied. In addition, the optimal volume of platelet transfusions has never been studied in neonates. This study will evaluate the response to 2 different volumes of platelet transfusion.

We hypothesize that a decrease in plasma TPO levels will be seen following a platelet transfusion in a population of neonates with thrombocytopenia. We also hypothesize that a platelet transfusion of 15 mL/kg will result in a greater rise in platelet count than a transfusion pf 10 mL/kg of platelets.

Conditions

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Thrombocytopenia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

10 mL/kg platelet transfusion

No interventions assigned to this group

2

15 mL / kg platelet transfusion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Preterm infants with thrombocytopenia
* Decision made by medical team to transfuse with platelets

Exclusion Criteria

* Infants with major congenital malformations
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Christiana Hospital

Principal Investigators

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Alex Kline, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Hospital

David A. Paul, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Hospital

Locations

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Christiana Hospital

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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CCC#23049

Identifier Type: -

Identifier Source: org_study_id

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